Spots Global Cancer Trial Database for A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
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Trial Identification
Brief Title: A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Official Title: A Two-arm, Phase 1b/2 Study of Duvelisib Administered in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
Study ID: NCT02391545
Conditions
Study Description
Brief Summary: A Two-arm, Phase 1b/2 Study of duvelisib Administered in Combination with Rituximab or Obinutuzumab in Subjects with Previously Untreated CD20+ Follicular Lymphoma.
Detailed Description: This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in subjects with previously untreated CD20+ FL. The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized, 2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting toxicity (DLT) within Part 1.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Los Angeles, California, United States
, Palo Alto, California, United States
, Hackensack, New Jersey, United States
, Rochester, New York, United States
, Dallas, Texas, United States
, Kortrijk, , Belgium
, Leuven, , Belgium
, Wilrijk, , Belgium
, Clermont-Ferrand, , France
, Marseille Cedex 05, , France
, Pessac, , France
, Rouen Cedex 1, , France
, Tours Cedex 01, , France
, Bologna, , Italy
, Varese, , Italy
, Badalona, Barcelona, Spain
, Barcelona, , Spain
, Madrid, , Spain
, Salamanca, , Spain
, Leeds, , United Kingdom
, London, , United Kingdom
Contact Details
Name: Hagop Youssoufian, MD
Affiliation: Verastem, Inc.
Role: STUDY_CHAIR
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